NX Development Corp (NXDC) has licensed and gained US FDA approval of Gleolan (aminolevulinic acid hydrochloride, known as ALA HCl), a real time real intra-operative imaging agent that assists surgeons by improving the visualization of Glioblastoma tumors during resection.

NXDC announced today that the U.S. Food and Drug Administration approved aminolevulinic acid hydrochloride, known as ALA HCl (Gleolan) as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery.

Enabling Selectivity: VisualizingWhat Counts

Over 60,000 patient exposures in 41 countries (excluding the U.S.) have had tumor resections enhanced by the use of Gleolan. NXDC’s new drug application with the FDA was approved in June 2017 with a commercial launch expected during the first half of 2018. Today over 90 prominent neurosurgeons have completed the necessary training to use Gleolan and fluorescent guided surgery with the goal of improving their patient outcomes.